OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 — FDA record Z-0054-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Reason
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Classification
Class I
Recalling firm
Olympus Corporation of the Americas
Quantity
59 units US; 665 units OUS
Agency-reported status
Ongoing
Source record identifier
Z-0054-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityModel No. BF-MP60; UDI: n/a; All Serial No.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide Distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Oct 22, 2025
Recall initiation date
Sep 11, 2025
Center classification date
Oct 16, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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